Sucralfate: a review of drug tolerance and safety.

The safety of sucralfate, an aluminum salt of sucrose octasulfate that is used to treat peptic ulcer disease, is based on data from clinical trials in over 2,000 patients. In vitro, animal, and clinical studies have shown that sucralfate does not have anticoagulant effects, in contrast to other sulfated polysaccharides. Sucralfate was well tolerated by healthy volunteers in a multiple-dose study, in which the drug was administered in doses two and three times higher than the normal treatment dose, for 14 and 28 days, respectively. In open-label trials conducted in Japan, France, and Latin America in 1,600 subjects, side effects were reported in only 44 subjects, with the most common complaint being constipation (in 23 subjects). In the United States, safety evaluations of sucralfate were similar to those obtained in other countries, with only 12.9% of subjects treated with sucralfate (232) reporting side effects. The incidence of side effects in the placebo-treated group was about 12.1%. Furthermore, sucralfate has been shown to heal ulcers comparable to antacids and cimetidine. Its therapeutic efficacy, combined with the fact that it is well tolerated and free of serious systemic effects, enhances sucralfate's therapeutic clinical usefulness in the treatment of peptic ulcer disease.